Drug Safety

, Volume 27, Issue 5, pp 283–292 | Cite as

Reassessing the Benefits and Risks of Alosetron

What is its Place in the Treatment of Irritable Bowel Syndrome?
Current Opinion


Functional gastrointestinal disorders such as the irritable bowel syndrome (IBS) cause substantial morbidity and a high amount of healthcare utilisation. However, no direct mortality can be attributed to functional disorders. Hence, drug treatment of IBS must not only be highly efficient to relieve clinical symptoms but also very safe for the long-term use in humans with such chronic disorders. Alosetron is a potent and highly selective serotonin 5-HT3 receptor antagonist that in large randomised controlled clinical trials has been shown to be clinically efficient in female patients with diarrhoea-predominant IBS. The efficacy data along with a low number of serious adverse effects in the preclinical and clinical trials suggested a favourable benefit/risk profile that led to US FDA approval of alosetron in early 2000. However, postmarketing experience has proven that several serious adverse effects, including death, occurred in the treated patient population, which resulted (for a time) in the withdrawal of alosetron from the US market by the producer (GlaxoSmithKline). In the meantime, both public pressure and the proposal of a careful postmarketing surveillance have led the FDA to re-approve alosetron to the US drug market under severe restrictions. These restrictions aim to ensure a safer use of the drug with a more favourable safety profile. Under these restrictions, however, it is not very likely that alosetron will become a major treatment option for many patients, but presumably the continued use of this first selective serotonin antagonist will open an avenue for the development of similar drugs with more favourable benefit/risk profiles in the near future.


Irritable Bowel Syndrome Irritable Bowel Syndrome Patient Colonic Transit Irritable Bowel Syndrome Symptom Alosetron 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



Dr Viola Andresen is currently employed as a clinical research fellow in Gastroenterology at the Department of Hepatology and Gastroenterology, University Hospital Charite, Berlin, Germany. Dr Stephan Hollerbach is currently affiliated as Chief of Gastroenterology at the Academic Teaching Hospital Celle, Hannover Medical School, Germany. He has published more than 40 peer-reviewed clinical and scientific articles including basic work about sensory perception in the GI tract. No sources of funding were used to assist in the preparation of this review and the authors declare to not being sponsored nor supported by any pharmaceutical company. The authors have no conflicts of interest that are directly relevant to the contents of this review.


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Copyright information

© Adis Data Information BV 2004

Authors and Affiliations

  1. 1.Department of Medicine, Division of Hepatology and GastroenterologyUniversity-Medicine Charité, Campus VirchowBerlinGermany
  2. 2.Department of Gastroenterology, Hannover Medical School, Allgemeines Krankenhaus CelleAcademic Hospital Celle (AKH)CelleGermany

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